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Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia (ARIES)

24. juni 2022 opdateret af: Allergan

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Subjects With Pseudophakic Presbyopia

Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia.

AGN-190584 is approved (in the United States) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. This study is double-masked meaning that neither the participants nor the study doctors will know who will be given AGN-190584 and who will be given vehicle (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to vehicle. Approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the US.

Participants will receive eye drops of AGN-190584 or vehicle once daily in the morning in each eye for 14 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study. The effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Dothan, Alabama, Forenede Stater, 36301
        • Trinity Research Group /ID# 243541
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85224
        • Arizona Eye Center /ID# 243897
    • California
      • Glendale, California, Forenede Stater, 91204-2500
        • Global Research Management /ID# 243544
      • Inglewood, California, Forenede Stater, 90301
        • United Medical Research Institute /ID# 243531
      • Newport Beach, California, Forenede Stater, 92663-3600
        • Salvay Vision /ID# 243828
      • Newport Beach, California, Forenede Stater, 92663-3637
        • The Eye Research Foundation /ID# 243524
      • Sacramento, California, Forenede Stater, 95815
        • Sacramento Eye Consultants /ID# 243538
    • Florida
      • Crystal River, Florida, Forenede Stater, 34429
        • Nature Coast Clinical Research - Crystal River /ID# 243519
      • Delray Beach, Florida, Forenede Stater, 33484
        • Segal Drug Trials, Inc /ID# 243521
      • Fort Myers, Florida, Forenede Stater, 33901
        • Eye Associates of Fort Meyers /ID# 243545
      • Jacksonville, Florida, Forenede Stater, 32204
        • Levenson Eye Associates Inc. /ID# 243532
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322-1013
        • Emory University /ID# 243534
      • Morrow, Georgia, Forenede Stater, 30260-4180
        • Clayton Eye Clinical Research, LLC /ID# 243530
      • Roswell, Georgia, Forenede Stater, 30076
        • Coastal Research Associates /ID# 243525
    • Kansas
      • Pittsburg, Kansas, Forenede Stater, 66762-2620
        • Kannarr Eye Care /ID# 243542
    • Kentucky
      • Edgewood, Kentucky, Forenede Stater, 41017-3415
        • Cincinnati Eye Institute- Edgewood /ID# 243810
      • Louisville, Kentucky, Forenede Stater, 40206-1738
        • The Eye Care Institute /ID# 243588
    • Michigan
      • Fraser, Michigan, Forenede Stater, 48026
        • Fraser Eye Center /ID# 244038
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64034
        • Silverstein Eye Centers /ID# 243546
    • New Jersey
      • Dover, New Jersey, Forenede Stater, 07801-1629
        • Eye Associates of North Jersey /ID# 243913
      • South Orange, New Jersey, Forenede Stater, 07079-1855
        • Northern New Jersey Eye Institute PA /ID# 243522
    • New York
      • Rochester, New York, Forenede Stater, 14618-2616
        • Rochester Ophthalmological Group PC /ID# 243539
    • Ohio
      • Powell, Ohio, Forenede Stater, 43065
        • EyeCare Professionals Inc /ID# 243938
    • Pennsylvania
      • Cranberry Township, Pennsylvania, Forenede Stater, 16066
        • Scott and Christie and Associates /ID# 243548
    • Tennessee
      • Maryville, Tennessee, Forenede Stater, 37805
        • University Eye Surgeons /ID# 243926
      • Smyrna, Tennessee, Forenede Stater, 37167
        • Advancing Vision Research /ID# 243529
    • Texas
      • Dallas, Texas, Forenede Stater, 75243
        • Key-Whitman Eye Center /ID# 243928
      • San Antonio, Texas, Forenede Stater, 78229
        • Eye associates /ID# 243526
      • San Antonio, Texas, Forenede Stater, 78229
        • Parkhurst Nuvision /ID# 244041
    • Utah
      • Draper, Utah, Forenede Stater, 84020-7133
        • Hoopes, Durrie, Rivera Research /ID# 243535
      • Ogden, Utah, Forenede Stater, 84403-2200
        • Country Hills Eye Center /ID# 243520
      • Saint George, Utah, Forenede Stater, 84790
        • Southern Utah Medical Research /ID# 243931

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • History of bilateral pseudophakia with monofocal intraocular lenses corrected for distance (noncomplicated cataract surgery), with identifiable intraocular lens type/brand, at least 3 months after surgery (prior to baseline), and be in stable condition.
  • If a participant has had neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy, it needs to be done bilaterally at least 1 month prior to baseline.
  • Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score >= 3) on at least 1 question on 25-Item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Questions 5 to 7 in the main questionnaire or Near Vision Subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions at the screening visit.
  • Best distance correction at screening in the range of spherical -1.50 D to +1.00 D inclusively and cylinder <= ±2.00 D with photopic high contrast binocular corrected distance visual acuity (CDVA) of 20/25 or better at the screening and baseline visits.
  • Mesopic, high contrast binocular distance-corrected near visual acuity (DCNVA) no better than 20/40 (J3) at screening and baseline visits.

Exclusion Criteria:

- Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters (e.g., uveitis, acute iritis, retinal detachment or retinal tear).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AGN-190584
Participants will receive one drop of AGN-190584 instilled in each eye once daily for 14 days.
Medicin: AGN-190584
Eye drops
Placebo komparator: Vehicle
Participants will receive one drop of vehicle instilled in each eye once daily for 14 days.
Medicin: Vehicle
Eye drops

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Experiencing Adverse Events (AEs)
Tidsramme: Up to approximately 14 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Up to approximately 14 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Allergan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

9. juni 2022

Primær færdiggørelse (Forventet)

4. april 2023

Studieafslutning (Forventet)

4. april 2023

Datoer for studieregistrering

Først indsendt

23. maj 2022

Først indsendt, der opfyldte QC-kriterier

23. maj 2022

Først opslået (Faktiske)

26. maj 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M21-194

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD-delingstidsramme

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD-delingsadgangskriterier

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med AGN-190584

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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